UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046539 |
|---|---|
| Receipt number | R000053088 |
| Scientific Title | Physical and mental effects of foot-bath among women in labor: A pre-post-test experimental design |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2026/01/08 09:57:17 |
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Basic information
Public title
Physical and mental effects of foot-bath among women in labor
Acronym
The effects of foot-bath among women in labor
Scientific Title
Physical and mental effects of foot-bath among women in labor: A pre-post-test experimental design
Scientific Title:Acronym
The effects of foot-bath among women in labor: A pre-post-test experimental design
Region
| Japan |
Condition
Condition
Women in labor
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the physical and mental effects of foot-bath using biomarker and self-administered questionnaire.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The salivary cortisol levels immediately after foot-bath
Key secondary outcomes
The levels of relaxation, comfort, labor pain, warmth of body, vital signs, and interval of labor pain immediately after foot-bath
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
For women in the first stage of labor, implement a foot-bath for 15 to 20 minutes using a foot-bath machine. The temperature of the hot water should be in the range of 38 to 42 degree Celsius, which is set to a temperature that the women feels comfortable with. During the foot-bath, do not apply any stimuli such as pushing the acupoints or massaging.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women in the first stage of labor or induction of labor.
Key exclusion criteria
Women who can not answer the questionnaire of have difficulty participating in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Isoyama |
Organization
Dokkyo Medical University
Division name
Graduate Program of Midwifery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
a-isoyama@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Hikita |
Organization
Dokkyo Medical University
Division name
Graduate Program of Midwifery
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
Homepage URL
nhikita-tky@umin.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
Tel
0282-86-1111
soumu@dokkyomed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.researchprotocols.org/2023/1/e39985
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jjam/38/Supplement_2/38_S1/_pdf/-char/ja
Number of participants that the trial has enrolled
20
Results
Salivary cortisol levels increased significantly after foot bathing (p=0.027). Refarding psychological changes before and after foot bathing, the subjective effects of comfort (p=0.001) and relaxation (p=0.002) were significantly higher. Regarding changes in labor contractions before and after foot bathing, there was a significant shortening of labor cycle time (p=0.048).
Results date posted
| 2026 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age was 30.5 years, the average length of pregnancy at the time of the survey was 38 weeks, there were 4 primiparas, 15 multiparas, 7 had used uterine contraction drugs, and 3 had experienced rupture of membranes.
Participant flow
Consent was obtained from 20 parturient women, of whom one withdrew due to the progression of labor, leaving 19 women for analysis (valid response rate: 95.0%).
Adverse events
Nothing
Outcome measures
Vital signs, salivary cortisol levels, mental changes before and after foot bathing (comfort, relaxation), labor cycle time, labor duration, pain
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053088
